RecruitingPhase 1NCT06349473

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)

A Phase 1 Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Healthy Participants (Part A) and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SR604 in Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency (Part B)


Sponsor

Equilibra Bioscience LLC

Enrollment

31 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B).


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called SR604 for people with factor vii deficiency, healthy participants, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSR604

SR604 will be administered as SC injection.

DRUGPlacebo

Placebo will be administered as single SC injection.


Locations(10)

California Clinical Trials Medical Group (CCTMG)

Glendale, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Rush University Medical Center

Chicago, Illinois, United States

LA Center for Bleeding and Clotting Disorders - Metairie

Metairie, Louisiana, United States

University of Michigan Hospitals - Michigan Medicine

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Penn State Milton S Hershey Medical Center Pediatrics

Hershey, Pennsylvania, United States

Perelman Center for Advanced Medicine (PCAM)- Penn Blood Disorders Program

Philadelphia, Pennsylvania, United States

McMaster University Medical Centre, Hamilton Health Sciences

Hamilton, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06349473


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